通用名称

voriconazole

儿科标签批准日期

2019/1/29 0:00:00

特定指示/秒

(1) Invasive aspergillosis (2) Candidemia and disseminated candidiasis in skin, abdomen, kidney, bladder wall, and wounds (3) Esophageal candidiasis (4) Serious infections caused by Scedosporium apiospermum and Fusarium species in patients intolerant of, or refractory to, other therapy.

标签更改摘要

- Expanded indications down to 2 years; previously approved in 12 years and older. - Safety and effectiveness have been established in pediatric patients 2 years of age and older based on evidence from adequate and well-controlled studies in adult and pediatric patients and additional pediatric pharmacokinetic and safety data. A total of 105 pediatric patients aged 2 to less than 12 [N=26] and aged 12 to less than 18 [N=79] from two, non-comparative Phase 3 pediatric studies and eight adult therapeutic trials provided safety information for Vfend use in the pediatric population. - Safety and effectiveness in pediatric patients below the age of 2 years has not been established. Therefore, Vfend is not recommended for pediatric patients less than 2 years of age. - The frequency of phototoxicity reactions is higher in the pediatric population. Squamous cell carcinoma has been reported in patients who experience photosensitivity reactions. Stringent measures for photoprotection are warranted. Sun avoidance and dermatologic follow-up are recommended in pediatric patients experiencing photoaging injuries, such as lentigines or ephelides, even after treatment discontinuation. - A higher frequency of liver enzyme elevations was observed in the pediatric patients. Hepatic function and serum creatinine levels should be closely monitored in pediatric patients. - There have been postmarketing reports of pancreatitis in pediatric patients. - Information on dosing, adverse reactions, PK parameters, and clinical studies. - Postmarketing study

治疗类别

Antifungal

立法类型

PREA + BPCA

产品说明书链接

书号

2.0 1.0

研究年龄

2 YEARS - 17 YEARS 2 YEARS - 17 YEARS

学习类型

Safety,Pharmacokinetic,Tolerability,Efficacy (extrapolated) Safety,Pharmacokinetic,Tolerability,Efficacy (extrapolated)

研究设计

Multicenter,Phase 3,Non-Randomized,Prospective,Open-Label Multicenter,Non-Randomized,Prospective,Open-Label,Phase 3b

登记的患者

22 31

患者分析

22 31

中心的数量

11 15

国家数量

8 7

西班牙裔拉美裔/拉丁裔总计

N/A N/A

非西班牙裔/非拉丁裔总人数

N/A N/A

总数#种族不明

0 0

亚裔学生总数

6 18

黑人总数

0 1

白人总数

10 11

夏威夷或太平洋岛民总数

0 0

美洲印第安人/阿拉斯加本地人总数

0 0

其他种族总计

6 1

未知种族总数

N/A N/A

国家

N/A N/A